A Study of Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation

Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation VIP BOLT Trial: A Multicenter Prospective Randomized Trial

The purpose of this research study is to compare the technique of performing bilateral lung transplantation off-pump vs venoarterial ECMO (VA ECMO). The goal of the trial is to determine which technique has lower rates of primary graft dysfunction.

Study Overview

• Status: Recruiting
• Conditions: Lung Transplant
• Intervention / Treatment: Procedure: Off-pump lung transplantation; Procedure: Venoarterial ECMO lung transplantation

Detailed Description

The Investigators of the Extracorporeal Life Support Registry in Lung Transplantation (ECLS Registry) has studied the impact of the type of intraoperative extracorporeal life support on primary graft dysfunction (PGD) after lung transplantation (LTx) in an international registry. The investigators have demonstrated that severe PGD at 48-72 hours is greater when LTx is performed using cardiopulmonary bypass (CPB) (43%) when compared to veno-arterial (VA) ECMO. However, PGD after VA ECMO remained high (29%) when compared to off-pump (12%). Conversely, there are retrospective series showing that when compared to off-pump technique, VA ECMO has reduced PGD rates and improved survival. Because selection bias and unknown confounders in retrospective studies could have been the cause of these conflicting results, part of the ECLS Registry Investigators are committed to a prospective multicenter randomized trial comparing off-pump versus VA ECMO LTx.

• Study Type: Interventional
• Enrollment (Estimated): 228
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mauricio Villavicencio, MD, MBA; Phone Number: 507-2557068; Email: villavicencio.mauricio@mayo.edu
• Study Contact Backup: Name: Jackie Reiter; Phone Number: 507-538-2224; Email: reiter.jacqulyn@mayo.edu

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • University of Louisville
      • Contact: Matthew Fox, Dr.; Phone Number: 502-587-4384
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic Rochester
      • Contact: Jacqulyn R Reiter; Phone Number: 507-538-2224; Email: reiter.jacqulyn@mayo.edu
      • Sub-Investigator: Suraj Yalamuri, MD
      • Contact: Mauricio Villavicencio Theoduloz, MD, MBA; Phone Number: 507-255-7068; Email: villavicencio.mauricio@mayo.edu
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
      • Contact: Gabriel Loor, MD; Phone Number: 832-355-3000; Email: gabriel.loor@bcm.edu
      • Principal Investigator: Gabriel Loor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Bilateral Lung Transplantation (LTx) recipients.
• Mean pulmonary artery pressure < or = 35 mmHg.
• Eligible for off-pump or VA ECMO based on the judgement of the attending surgeon.

Exclusion Criteria:

• Single lung transplant
• Multiorgan transplant.
• Donor after cardiac death (DCD).
• Re-transplant.
• Intention to use prophylactic post-operative ECMO.
• Previous major lung surgery. Video-assisted thoracoscopic surgery (VATS) and wedge resection are not an exclusion criterion.
• Previous pleurodesis.
• Preoperative ECMO and/or mechanical ventilation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Off-Pump Bilateral Lung Transplantation; Subjects will receive 'off-pump' technique for lung transplantation as part of standard of care	Procedure: Off-pump lung transplantation; General anesthesia, intubation with double lumen tube, thoracotomies or clamshell incision, pneumonectomy starting by the less perfused lung in the scan, stump preparation, lung implantation, reperfusion, gradual release of the pulmonary artery clamp, deairing, ventilation of the 1st implanted lung. The process is repeated at the contralateral side. Ventilation of both lungs, chest closure.
Active Comparator: Venoarterial Extra Corporeal Membrane Oxygenation (VA ECMO) Bilateral Lung Transplantation; Subjects will receive VA ECMO technique for lung transplantation as part of standard of care	Procedure: Venoarterial ECMO lung transplantation; General anesthesia, intubation with double lumen tube, thoracotomies or clamshell incision, heparin, peripheral or central venoarterial ECMO cannulation, first pneumonectomy, stump preparation, lung implantation, reperfusion, release of the pulmonary artery clamp, deairing, ventilation of the 1st implanted lung. The process is repeated at the contralateral side. Ventilation of both lungs, ECMO decannulation, chest closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Lung Graft Dysfunction (PGD) grade 3	Rate of PGD according to the The International Society for Heart and Lung Transplantation (ISHLT) classification	48-72 hours
Mortality	Death rate of subjects following lung transplantation	90 days
Primary Lung Graft Dysfunction (PGD) grade 3 and Mortality	Rate of PGD according to the The International Society for Heart and Lung Transplantation (ISHLT) classification plus the Death rate of subjects following lung transplantation	48-72 hours and 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Red blood cell transfusions	Number of subjects to require red blood cell transfusions	Intraoperative plus the first 24 hours in the ICU
Chest tube output	Chest tube output the first 24 hours following lung transplantation reported in cubic centimeter (cc)	First 24 hours
Incidence of re-exploration for bleeding	Number of subject to require re-exploration for bleeding	First 48 hours
Incidence of air emboli	Number of subjects to experience air emboli	During VA ECMO run
Incidence of stroke	Number of subjects to experience stroke	90 days or discharge from the index hospitalization
Incidence of Primary Lung Graft Dysfunction (PGD) grade 3	Number of subjects to experience a PGD grade 3 following lung transplantation. PGD will be rated according to the The International Society for Heart and Lung Transplantation (ISHLT) classification	At 0 hours (ICU arrival) and 24 hours
Incidence of pneumonia	Number of subjects to experience pneumonia	90 days or discharge from the index hospitalization
Incidence of need for dialysis	Number of subjects to need dialysis	90 days or discharge from the index hospitalization
Incidence of transplant rejection	Number of subjects to experience transplant rejection	90 days or discharge from the index hospitalization
Incidence of bronchial dehiscence	Number of subjects to experience bronchial dehiscence	90 days or discharge from the index hospitalization
Incidence of tracheostomy	Number of subjects to require tracheostomy	90 days or discharge from the index hospitalization
Length of mechanical ventilation	Total amount of time subjects require mechanical ventilation following lung transplantation	90 days or discharge from the index hospitalization
Length of stay	Total amount of time subjects are hospitalized	90 days or discharge from the index hospitalization

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Mauricio Villavicencio, MD, MBA, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Research Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Bilateral
• Other Study ID Numbers: 22-005691

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No